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Male Partner Involvement in the Prevention of MTCT of HIV

This study has been completed.
Sponsor:
Collaborator:
University of Cape Town
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00405990
First received: November 30, 2006
Last updated: May 8, 2008
Last verified: May 2008

November 30, 2006
May 8, 2008
November 2006
December 2007   (final data collection date for primary outcome measure)
Percentage of partners agreeing to attend VCT. [ Time Frame: 12 weeks ]
  • Percentage of partners agreeing to attend VCT.
  • Percentage of pregnant women inviting their partners for VCT.
  • Percentage of partners undergoing HIV testing.
Complete list of historical versions of study NCT00405990 on ClinicalTrials.gov Archive Site
Percentage of partners and pregnant women abstaining, faithful to one partner and using condoms consistently. [ Time Frame: 12 weeks ]
Percentage of partners and pregnant women abstaining, faithful to one partner and using condoms consistently.
Not Provided
Not Provided
 
Male Partner Involvement in the Prevention of MTCT of HIV
Optimizing the Impact of Prevention of Mother to Child Transmission of HIV in South Africa: the Forgotten Half of the Equation.

The study aims to invite male sexual partners to attend antenatal clinic with their pregnant partners to either acquire pregnancy information or undergo voluntary counselling and testing for HIV. To see if male sexual partner involvement will decrease sexual risk behaviour.

We will enrol 1000 pregnant women; recruited from antenatal clinic at Khayelitsha Midwive and Obstetric Unit (MOU). Community sensitization activities will be implemented in the catchment community to encourage male partner participation.

At the booking visit all women will be offered antenatal care, HIV group education and VCT as usual. Thereafter women will be recruited to enrol into the study, after signing the consent form half of the cohort members will be randomly assigned to partner VCT (Group A) and half to partner pregnancy information (Group B). Men in group B will be offered VCT at the second interview late in pregnancy. However, VCT will be provided if requested by study participants at any stage of the study or if the female partner is HIV positive. Women in group A will be given a written invitation to hand to their partners to encourage them to invite their partners to come to the antenatal clinic for VCT. In group B, women will be given a written invitation to give to their partners to encourage their partners to attend a pregnancy information session at the antenatal clinic.

VCT will be offered again close to delivery for all women and men who were previously uninfected or of unknown status. For those found to be HIV-infected at a prior visit, CD4 and CD8 T-cell counts, viral load, and full blood count tests will be conducted. Both women and men will be referred to the Antiretroviral clinic where ARV will be offered if appropriate and formula feeding (or exclusive breastfeeding) will be recommended. Reasons for declining VCT and data on sexual behaviour and violence will be sought at each visit.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
HIV Infections
  • Behavioral: Voluntary counselling and HIV testing in ANC for PMTCT
    VCT for 30 minutes in ANC
    Other Names:
    • ANC VCT
    • VCT for PMTCT
  • Behavioral: VCT
    HIV VCT for PMTCT
    Other Name: VCT for PMTCT
Not Provided
Mohlala BK, Boily MC, Gregson S. The forgotten half of the equation: randomized controlled trial of a male invitation to attend couple voluntary counselling and testing. AIDS. 2011 Jul 31;25(12):1535-41. doi: 10.1097/QAD.0b013e328348fb85.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
May 2008
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • To be eligible for participation, a woman must be less than 30 weeks pregnant at enrolment.

Exclusion Criteria:

  • Women who are more than 30 weeks pregnant will be excluded.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00405990
cro625
Yes
Not Provided
Imperial College London
University of Cape Town
Principal Investigator: Boshishi K Mohlala, MBCHB FCOG MSC Imperial College London
Imperial College London
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP